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Intracavitary Urokinase for Enhancement of Percutaneous Abscess Drainage

Phase II Trial

¹ Department of Radiology, University Hospitals of Cleveland, Case Western Reserve University, 11100 Euclid Ave., Cleveland, OH 44106-5056.
² Department of Radiology, University of Tennessee Medical Group, Inc., and the University of Tennessee, 800 Madison Ave., Memphis, TN 38163.
³ Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St., Boston, MA 02115.
⁴ Block, McGibany, Bellmore & Associates, Inc., 3609 Woodvalley Dr., Baltimore, MD 21208.

Received March 8, 1999; accepted after revision November 12, 1999.

 
Supported in part by Abbott Laboratories, Abbott Park, IL.

Address correspondence to J. R. Hagga.

Abstract

Top Abstract Introduction Subjects and Methods Results Discussion References

 
OBJECTIVE. To evaluate the effectiveness of urokinase as an abscess-cavity irrigant during percutaneous abscess drainage.

SUBJECTS AND METHODS. In a prospective study, approved by the Food and Drug Administration and the review board at our institution, urokinase and saline were used as abscess-cavity irrigants. In the study group of 42 patients, half the patients were randomly placed into the urokinase group and the other half were placed into the control saline group. Doses used varied with the size of the abscess. Data collected from patient charts were evaluated with standard statistical methods.

RESULTS. The results indicate definite benefits of the urokinase treatment. The length of stay (p = 0.0025) and treatment costs (p = 0.0021) were significantly less for the urokinase group. Other clinical parameters, including the febrile course, elevated WBC, and days of drainage, trended in a favorable fashion.

CONCLUSION. Urokinase injected intracavitarily is an effective technique for shortening the treatment time and improves the clinical course for patients treated with percutaneous drainage techniques.

Introduction

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Since its introduction and refinement, percutaneous abscess drainage has become the most widely accepted method of abscess treatment. Although generally successful, specific outcomes of this procedure vary among institutions and authors, depending on the patient selection and the specifics of individual treatment regimens. Technical variations have included different types of imaging guidance and catheters and postprocedural care of drainage catheters [1,2,3,4,5,6,7,8,9,10]. Two abscess properties have been reported consistently by most authors for causing poor results: the presence of infected hematomas and viscous, thick, purulent material. In several earlier studies, our group reported the potential benefit of urokinase (Abbokinase; Abbott Laboratory, Chicago, IL) for treating abscesses, especially those with thick purulent material, old blood, or loculations [11, 12]. This report describes the early results of a Food and Drug Administration-approved phase II study comparing the effectiveness of intracavitary urokinase to that of saline as a catheter irrigant for improving the drainage of abscesses.

Subjects and Methods

Top Abstract Introduction Subjects and Methods Results Discussion References

 
A prospective sample of 38 patients who presented at University Hospitals of Cleveland was used for this analysis. A total of 42 patients were initially enrolled, 21 patients in the saline solution and 21 in the urokinase group, but complete clinical data were obtained for only 38 of the 42 enrollees. The study was approved by our institutional review board for human investigation.

All patients between the ages of 18 and 95 years who presented with an abscess and under-went percutaneous abscess drainage were included in this study. The fluid collection being drained was considered an abscess and qualified for the study if the material was culture positive for organisms or if the attending physician clinically treated the patient for an abscess. Culture-negative abscesses were included if by clinical criteria they were considered abscesses by the attending physicians; this was accepted because when patients are on antibiotic therapy, as all these patients were, cultures may be negative despite the presence of infection. In our patients, the attending physician for the patient stated that the patient had an abscess on the basis of fever, elevated WBC, and other clinical signs to warrant catheter drainage and antibiotic treatment. Culture- negative pancreatic "abscesses" were excluded because we did not want to inadvertently treat pancreatic pseudocysts. Pseudocysts are known to have pseudoaneurysms and we did not want to use a fibrinolytic agent, which might cause bleeding. The patients were enrolled only during the first 24 hr after placement of the drainage catheter.

Exclusion criteria for this study included pancreatic abscess that was not bacterial in nature, coagulation impairment, known central nervous system tumor, abscesses, arteriovenous malformation, aneurysm or history of central nervous system bleeding, hypersensitivity to urokinase, recent administration of an investigational drug, pregnancy, breast-feeding, or fulminant hepatic failure. These criteria were chosen because they are the accepted standard exclusion criteria for the vascular use of urokinase. It was our belief that similar standards should be used for intracavitary use of urokinase.

After informed consent, patients were randomly assigned to one of two groups, saline solution or urokinase, on the basis of a computer-generated randomization assignment. The assignment was obtained from a sealed envelope. The attending radiologist planned and performed the abscess drainage and recorded anatomic trajectory, number, size, and type of catheter(s).

During the 4 days after catheter placement, either saline solution or urokinase was injected at 8-hr intervals. For the treatment group, the dose of urokinase used depended on the size of the abscess as follows: 1-3 cm, 12,500 U (3 ml); 3-5 cm, 25,000 U (5 ml); 5-10 cm, 50,000 U (10 ml); and more than 10 cm, 100,000 U (10 ml). After injection of urokinase through the catheter, the catheter was then cleared with a 10-ml bolus of saline solution. The abscess catheter was clamped for 15 min and then unclamped, permitting the fluid to drain. Patients randomly selected for the saline control group received a 10-ml saline solution injection on the same schedule. Catheters were not checked routinely but were removed or readjusted when less than 10-ml full.

Data were collected during treatment. Minor omissions or inconsistencies in the data were retrospectively corrected via chart review. Outcome was recorded as either success or failure. Success was defined as complete resolution of an abscess on physical examination and normal laboratory findings without any intervention other than the percutaneous drainage. The criteria for catheter removal was the same for both groups; the catheter was removed after the drainage from the catheters was less than 10 ml for 3 days. Other clinical measures evaluated included duration of the febrile course, WBC elevation, and the number of days of drainage (defined as 10 ml/day). Treatment cost data for each patient were derived from hospital fiscal records. Treatment cost was calculated from the time of catheter placement until the patient was discharged.

Data concerning other factors related to the abscess and drainage, including abscess size, character (loculations, hematoma, and so forth), location, catheter size, and drainage method (suction, gravity, and so forth) were recorded; however, the numbers in each category were not sufficiently large to permit statistical analysis. Associated medical conditions such as congestive heart failure and cancer were not controlled because the sample was not large enough, but our complete review of charts showed no instances of prolongation of length of stay caused by concurrent disease.

Clinical data were collected on paper forms and encoded onto electronic media. Data analyses were performed using Systat version 7 statistical software (Statistical Package for the Social Science, Chicago, IL) on a Dimension 20 computer (Dell, Austin, TX) before analysis data were evaluated for normality and homogeneity of variance. Transformations were not required to meet assumptions of univariant normality; Levene's test [13] was used to assess homogeneity of variance. If variance of groups was not found to be homogeneous, the separate variance t test was used. Otherwise, the standard Student's t test was used. Differences in success or failure of treatment were measured using the chi-square test of independence. For all statistical tests, p < 0.05 was considered to be statistically significant. Financial data were calculated as the average cost per day and the average cost of the entire hospital stay.

Results

Top Abstract Introduction Subjects and Methods Results Discussion References

 
The resulting success or failure of abscess remission was not significantly different. (Only 38 of 42 patients had complete clinical data, but tabulation of success, partial success, or failure were available for all patients.) The control group had 12 successes, six partial successes, and three failures. The urokinase group had 13 successes, five partial successes, and three failures. However, the results suggested that the use of urokinase as an adjuvant to saline solution in percutaneous abscess drainage significantly reduced the length of patient stay and the total and average daily costs after catheter insertion. The financial data was based on charges, rather than costs or receipts paid. Febrile course, days with elevated WBC, and duration of abscess drainage were not found to be statistically significant, but a definite favorable trend was noted (Table 1). Chart review of all patients was performed and none of the patients in either group had a concurrent illness or problem develop during abscess drainage that affected the length of stay.

The proportion of abscesses with loculations was not found to be significantly different between the two groups; from data collected, five (40%) of 16 in the urokinase group and seven (33%) of 21 in the saline group had loculations. However, when the data of patients with loculated abscesses were evaluated separately from those of patients without loculations, the difference in the treatment cost was statistically significant, but not the length of stay (although an absolute difference existed) (Table 2). Other factors noted, including size of abscess cavity, location of abscess, size of catheter, and number of catheters, could not be evaluated because not enough cases existed in each category to statistically evaluate them. These factors were similar in the two groups (Table 3).

Discussion

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Since the introduction and development of percutaneous abscess drainage 20 years ago, it has become the treatment of choice for abscesses. Numerous authors have reported their results using this technique, with only minor variations in the diagnostic methods, guidance techniques, and instrument selection. Haaga and Weinstein [2] reported the first percutaneous drainage using CT guidance, but other authors, including Gerzof et al. [3], Jacques et al. [4], Lambiase et al. [5], Gazelle and Mueller [6], Mueller et al. [7], and vanSonnenberg et al. [9,10], have described specific techniques and results. During the early development of this technique, some controversy arose over the best imaging technique and, although most radiologists now recognize that any technique may be used for percutaneous drainage, many prefer CT for the diagnosis, staging, and follow-up of abscess drainage.

The differences among these various reports include philosophy of patient selection, anatomic trajectory preferences, guidance techniques, and types of catheters. To our knowledge, no controlled studies were performed by these groups, so proof of definite benefit from variations in technique was difficult to confirm. Problems with drainage or causes of failure varied among these groups, but authors such as Haaga and Weinstein [2], Gerzof et al. [3], Jacques et al. [4], Mueller et al. [7,8], and vanSonnenberg et al. [9] noted that increased viscosity of thick purulent material affected drainage success.

A logical refinement of the drainage technique was the irrigation of catheters and cavities with different medications. Authors reporting on abscess drainage have different opinions on the need for irrigation of the drainage catheters, but most irrigate the catheter with at least saline. The two potential risks of such irrigations are the introduction of another pyogen and injecting with an excessive amount of fluid. Introduction of other pyogens is unlikely considering the high concentration of existing pathogens within an abscess. Injecting an excessive amount of fluid into an abscess cavity could cause a transient bacteremia; this risk is minimized by limiting the amount of irrigant to a small volume.

The earliest reports of injecting catheter irrigants other than saline solution were regarding surgically placed chest tubes. Authors such as Tillet et al. [14], Bergh et al. [15], and Berglin et al. [16] used streptokinase injected through chest tubes to improve the drainage of empyemas. In 1983, van Waes et al. [17] attempted to use a surface-active agent, acetyl cysteine (Mucomist; Bristol Myers Squibb, Princeton, NJ), to lessen the viscosity of purulent material. This met with only limited success and was not widely accepted because no corroboration by other investigators followed. Since 1983, the possibility of using fibrinolytics for abscesses was reported for infected hematomas by Vogelzang et al. [18] in 1987 and for typical abscesses by Haaga [19] in 1988.

Renewed interest in percutaneous procedures rekindled interest in the use of fibrinolytics to improve treatment of empyemas. As a result of the report of Moulton et al. [20] describing the efficacy and cost-effectiveness of urokinase for drainage of chest fluid collections, this method has become widely applied.

The rationale for the use of fibrinolytics for treating abscesses outside of the chest was first suggested by Haaga [19], Park et al. [11], and Lahorra et al. [12]. Park et al. showed in an in-vitro model that the use of urokinase decreased the viscosity of purulent material by 23% compared with untreated material. In a Food and Drug Administration—approved phase I study, Lahorra et al. showed that intracavitary administration of urokinase was clinically advantageous for a number of reasons. First, purulent material contains a high level of fibrin. Second, urokinase injected into purulent material retains its enzymatic properties and splits the fibrin found in abscesses into smaller fragments. Third, urokinase has no significant side or systemic effects.

The mechanisms of urokinase used for this purpose can be appreciated by considering both its basic pathophysiology related to infection and the kinetics of fibrinolytic agents. After the introduction of a pyogen, the body defenses respond with an influx of inflammatory cells that release a number of kinins, thereby producing increased capillary permeability. With increased vascular permeability, large protein molecules, such as fibrinogen, leak into the tissue space and polymerize into fibrin. The fibrin then acts to limit the local spread of infection, which is helpful in the short term but probably impairs the body's elimination of these bacteria. Contained in fibrin, these pyogens are shielded from the phagocytes and exposure to the antibiotics. The creation of fibrinous barriers prevents the spread of an untreated abscess but also delays the overall drainage of purulent material after a drainage catheter has been inserted. Several animal models have clearly shown this effect. Hau et al. [21] showed that trapping bacteria in fibrin clots decreased the efficacy of systemic antibiotics. These researchers found that the concentration of antibiotics in the peritoneum was essentially equivalent to that of the serum level, and the concentration in the fibrin clot containing bacteria was low or undetectable. Hau and Simmons [22] showed in an animal model that treatment with heparin improved the outcome of peritonitis, presumably by preventing additional fibrin production and the subsequent entrapment of bacteria.

Several comments about the concentration of plasminogen or plasmin in the abscess cavity should be made. In our phase I study [12], we tried to perform chemical assay of the plasmin in the purulent materials, but we could not find a laboratory that would evaluate the samples from human sources. In the phase I study, we were able to infer the presence of sufficient plasmin to produce fibrinolysis by measuring serum levels of fibrin split products during the urokinase treatment. In the phase I study, serum levels of fibrin split products were elevated 3—4 times above normal, to a statistically significant level, during the urokinase treatment. After the cessation of treatment, levels returned to normal.

Urokinase is a hydrolase enzyme that cleaves plasminogen to the active protease, plasmin. Plasmin, in turn, degrades a variety of proteins, including the fibrin contained in an inflammatory focus or in an abscess. Streptokinase, derived from bacterial sources, is a fibrinolytic agent that acts by forming a complex with plasminogen and causing a conformational change that activates the latter enzyme.

A number of animal models confirmed the benefit of fibrinolytic agents and heparin for clearing infection. Other authors showed that heparin improved the clearance of peritonitis [23,24,25,26,27]. Nakamoto et al. [28,29] showed in two animal models that direct injection of urokinase into an abscess caused by a contaminated foreign body improved the outcome. In the first animal study by Nakamoto et al. [28] using pieces of Goretex (W. L. Gore, Flagstaff, AZ) dipped in staphyloccal broth and inserted into the subcutaneous tissues of a hamster, the incidence of infection was reduced in both the antibiotic-treated group and the group treated with urokinase only. Further insights and information were gained in a second report by Nakamoto et al. [29] investigating the effect of urokinase for treatment of a metal foreign body infection. In the second hamster model, Nakamoto et al. im-planted pieces of angiographic wire in groups of untreated, urokinase-coated, and heparin-coated hamster abscesses and found that almost half of the foreign bodies became sterile in the group treated with urokinase.

Some of our results were statistically significant, and other clinical indicators of response and outcome were not statistically significant, but had a favorable trend. For example, the length of hospital stay and cost for those patients who were treated with urokinase was noticably reduced (Tables 1 and 2). The causes of increased cost are related to not only the length of stay but also the intensity of treatment and other associated problems. The scope of this study did not evaluate these factors. The clinical parameters of fever (p = 0.12), WBC (p = 0.17), and duration of drainage (p = 0.14) were significantly improved in the treatment group, but the results were not statistically significant. Although one can never be absolutely confident that some unknown bias does not exist, our two consulting statisticians concur that using a prediction method, a larger study group would show statistical significance in most of the tabulated parameters.

These results were obtained from a randomly selected group of patients with abscesses. Because of the small size of the study group, the patients were not stratified according to loculation size or location. If the patients in the group with abscesses containing loculations were separated, the difference in costs of treatment are statistically significant for the treatment group compared with those of the saline group. For length of stay, the urokinase treatment group shows a statistically significant difference for the treatment group in patients without loculations and a very strong tendency for statistical difference in the treatment group with loculations. Our statisticians predict that with a larger group sample statistical significance would also occur in the group with loculations.

Although some aspects of our study were not ideal, we do not believe that they have significantly flawed the study outcome. Our average drainage time was greater than has typically been reported and we believe this may have occurred because of the enrollment process. We strictly adhered to our selection criteria and randomization, but patients' choices may have skewed the entire group. Our impression is that as we tried to enroll patients into the study only the most seriously ill agreed to participate. Many who were not very ill refused to participate. If more seriously ill patients were enrolled, the length of patient hospital stay and abscess drainage time were longer than average in our study group. This selection bias toward more seriously ill patients is well recognized in outcome research and is discussed in standard textbooks [30]. We do not believe an attempt at retrospectively categorizing the severity of these patients' illnesses would be accurate. The average size of the drainage catheters was smaller than 10 French, but the control group had more large-size catheters so any potential bias would be against urokinase. Finally, the rigorous statistical methods applied by two statisticians most likely evaluated the impact of the data variations.

In conclusion, the routine use of intracavitary urokinase resulted in a statistically significant shortened length of hospital stay and lower cost of treatment in our study group. Improvement of the clinical parameters of fever, WBC, and drainage duration tended toward significance, but a larger study group will be needed to make that determination. Based on this study, one should consider the use of urokinase as a catheter irrigant on a routine basis in all patients who have an abscess drained percutaneously, especially if the catheter is less than 10 French. The Food and Drug Administration has temporarily suspended the sale of urokinase pending resolution of some manufacturing control issues. Because of the positive results of this study, we recommend other studies be performed with plasminogen activators, such as tissue plasminogen activators, to determine if they are as effective as urokinase. Because this study was so innovative and the study group was small, it was not possible to stratify these cases. Therefore, the clinical measurement parameters had wide results. We are hopeful that an additional study can be conducted to improve the statistical reliability of these results.

References

Top Abstract Introduction Subjects and Methods Results Discussion References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Haaga, J. R. Articles by Bellmore, M. Search for Related Content PubMed PubMed Citation Articles by Haaga, J. R. Articles by Bellmore, M. Social Bookmarking                      What's this?